Kristen PollockMcDonald

Partner

Atlanta + 1.404.581.8498

Connect:

Share

Kristen McDonald defends providers in False Claims Act litigation brought by federal and state agencies and qui tam whistleblowers. Her civil fraud experience involves billing, coding, medical necessity, eligibility, physician compensation, and potential liability under the Stark Law and Anti-Kickback Statute. Kristen defends providers in government extrapolated audits, and she conducts internal investigations including assistance with repayments and self-disclosures. Additionally, she conducts internal investigations associated with HIPAA/HITECH concerns and defends providers in OCR investigations. She also defends providers in government enforcement actions involving civil money penalties and termination.

In addition, she has extensive experience conducting health care due diligence reviews for mergers, acquisitions, investments, and banking matters, focusing on fraud and abuse and other regulatory and compliance concerns. Kristen routinely advises health care and life science companies and related investors on fraud and abuse analyses, telemedicine services and reimbursement, HCP arrangements, conditions of payment, and compliance program effectiveness reviews.

Kristen has represented hospitals/health systems; hospice, home health, skilled nursing, and other post-acute care providers; life science companies including pharmaceutical, medical device, and biologics manufacturers and distributors; telehealth companies; AI companies; diagnostic imaging; ambulance suppliers; DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies); financial institutions; and private equity investors.

Kristen is a member of the American Health Lawyers Association and served as chair of AHLA's Health Care Liability and Litigation Practice Group.

Kristen has written and spoken extensively on health care issues, including risks and liabilities in telemedicine, meaningful use incentive payments and audits, program integrity audits, government recoveries, risk areas for post-acute care, and strategies for diligence reviews.

Experience

  • Organon makes strategic investment in Claria MedicalJones Day advised Organon in the strategic investment in Claria Medical, Inc. a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy.
  • Riverside portfolio company acquires Jupiter Life Science Consulting (Jupiter)Jones Day advised The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of Jupiter Life Science Consulting (Jupiter), a leading provider of commercial and market access strategies for global pharma, biotech, and medical device companies with its primary focus in rare disease, hematology/oncology, metabolic, and neurology therapeutic areas.
  • Riverside portfolio company acquires RockpointeJones Day represented The Riverside Company in connection with the acquisition by portfolio company Clinical Education Alliance (CEA) of Rockpointe, Inc., a premier healthcare education company providing accredited continuing education activities and related training for healthcare professionals.
  • Cardinal Health acquires the Bendcare CPO-GPO entity and makes a minority investment in the Bendcare MSOJones Day advised Cardinal Health, Inc. in the acquisition of the Bendcare group purchasing organization (CPO-GPO) entity and a minority investment in the Bendcare management services organization (MSO).
  • City of Hope acquires Cancer Treatment Centers of AmericaJones Day advised City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, in connection with its acquisition of Cancer Treatment Centers of America, a network of oncology hospitals and outpatient care centers across the United States.
  • STERIS sells renal business to EvoquaJones Day advised STERIS in the $196.3 million sale of its Renal Care business to Evoqua Water Technologies, a leading provider of mission-critical water and wastewater treatment solutions.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • Bridge to Life announces first close of $56 million growth financingJones Day advised Bridge to Life, Ltd. in its $56 million capital raise consisting of a secured credit facility and a Series A preferred equity investment.
  • STERIS acquires Cantel Medical for $3.6 billionJones Day advised STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • MedShape acquired by DJOJones Day advised MedShape, Inc., a privately held orthopedic medical device company founded in 2005, in connection with its acquisition by DJO, a subsidiary of Colfax Corporation.
  • MDLIVE sells company to Cigna's EvernorthJones Day advised MDLIVE in its sale to Cigna's health services subsidiary Evernorth.
  • Riverside portfolio company acquires PPM Advisory Group and OrtleyBioJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus of PPM Advisory Group and OrtleyBio, leading providers of scientific operations and communications services to global biopharmaceutical companies and brands, with a primary focus on oncology and hematology therapeutic areas.
  • PWNHealth and Home Access Health Corporation sold to Everlywell, forming Everly HealthJones Day advised PWNHealth LLC and Home Access Health Corporation in its sale to Everlywell, a leading digital health company, and forming Everly Health.
  • Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.
  • AbbVie acquires Mitokinin, Inc.Jones Day advised AbbVie Inc. in its exclusive right to acquire Mitokinin, Inc., a biotechnology company developing PINK1-targeted therapeutics for the treatment of neurodegenerative diseases, following completion of IND enabling studies on Mitokinin's lead PINK1 compound.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • Zyter acquires Casenet® LLCJones Day advised Zyter, Inc., a wholly owned subsidiary of Infinite Computer Solutions, Inc. and a leading digital health product company, in its acquisition of Casenet® LLC, a leading provider of population health products, from Cetene Corporation (NYSE: CNC).
  • Smith & Nephew acquires Extremity Orthopedics business of Integra LifeSciences Holdings Corporation for $240 millionJones Day advised Smith & Nephew plc, the global medical technology company, in its acquisition of the Extremity Orthopedics business of Integra LifeSciences Holdings Corporation (NASDAQ: IART) for $240 million on a cash and debt-free basis.
  • STERIS acquires Key Surgical for approximately $850 millionJones Day advised STERIS plc (NYSE: STE) in the $850 million acquisition of Key Surgical, a leading global provider of sterile processing, operating room, and endoscopy products, and a portfolio company of Water Street Healthcare Partners, LLC.
  • SOC Telemed merges with Healthcare Merger Corp.Jones Day provided healthcare and general corporate counsel to SOC Telemed, Inc. in its $720 million merger with Healthcare Merger Corp.
    • View All

    February 2023 Commentary

    2022 False Claims Act Statistics Reveal More New Cases and More Settlements (But Lower Total Recoveries)

    February 2023 Alert

    Consumer Health Information and Increased Scrutiny: FTC Brings First Action Under Health Breach Notification Rule

    March 2022 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2022

    February 2022 Alert

    DOJ Announces Second-Largest Annual Total Recoveries in False Claims Act History

    February 2022 Commentary

    Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

    September 2021 Commentary

    Federal Enforcement Keeps Pace with the Expansion of Telemedicine Services

    August 2021 Commentary

    Federal Court of Appeals Emphasizes Only Defendants Who Act "Knowingly" Can Be Liable Under the False Claims Act

    August 2021 Newsletters

    Vital Signs: Digital Health Law Update | Summer 2021

    JUNE 2021 Alert

    DOJ Ramps Up Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19

    April 2021 Newsletters

    Vital Signs: Digital Health Law Update | Spring 2021
    View All

    Additional Publications

    • October 20, 2015
      AseraCare Update: Jury Finds Majority of Sampled Claims False, AseraCare Seeks JMOL Following Phase One of Bifurcated Trial, American Health Lawyers Association Practice Group, Email Alert
    • August 28, 2015
      Fifth Circuit Requires Pharmacies to Arbitrate Claims Against Non-Signatories to Arbitration Agreement, American Health Lawyers Association Practice Group Email Alert
    • December 27, 2013
      Another Record Year for Government Recoveries under the False Claims Act, American Health Lawyers Association Practice Group, Email Alert
    • October 2013
      What Hospitals Need to Know About ZPIC Audits, Healthcare Financial Management Association
    • November 2012
      What do you do when a ZPIC comes knocking? Compliance Today, Health Care Compliance Association
    • August 29, 2012
      Beware of the Minefield - The New Survey and Enforcement Landscape for Home Health Agencies, The American Health Lawyers Association's Healthcare Liability and Litigation Health Briefs
    • February 1, 2012
      The Various Weapons in the ZPIC Arsenal, The American Health Lawyers Association's LTC-SIR Advisor
    • December 22, 2011
      Why the Anti-Kickback Statute May Be the Tip of the Iceberg When It Comes to Questionable Vendor Arrangements, The American Health Lawyers Association's LTC-SIR Advisor
    • May 2011
      Nursing Homes May Find Some Solace Amid the Storm of New Regulations Governing the Assessment of CMPs, American Health Lawyers Association's Healthcare Liability and Litigation Practice Group, May 2011 Health Briefs e-Newsletter
    • June 21, 2010
      Has a Trap Been Set? - What Risks Lie Ahead for Nursing Homes Compelled to Disclose Organizational Information under the Patient Protection and Affordable Care Act, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs
    • February 17, 2010
      New Guidance on the Indicia of Reliability Standard: What Now Faces Potential Relators in False Claims Act Litigation, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs

    Speaking Engagements

    • April 21, 2020
      Part 2: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 14, 2020
      Part 1: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 15, 2019
      The Evolving Landscape of Telehealth: Politics, Policy, Operations and Oversight, American Telemedicine Association
    • February 24, 2015
      Long Term Care and the Law: Why Long Term Care Providers are Finding New Uses for ADR: Best Practices for an Evolving Landscape, American Health Lawyers Association
    • February 19, 2015
      Due Diligence Reviews in Healthcare Transactions, Jones Day's CLE Academy
    • December 17, 2013
      Advocating Effectively in Health Care Arbitrations, American Health Lawyers Association
    • November 2011
      Beware of the ZPIC - Tips and Tactics from the Trenches, American Health Lawyers Association
    • Fall 2009
      Federal and state efforts to improve patient safety and reduce medical errors, Patient Safety and Never Events

    Before sending, please note:

    Information on www.jonesday.com is for general use and is not legal advice. The mailing of this email is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Anything that you send to anyone at our Firm will not be confidential or privileged unless we have agreed to represent you. If you send this email, you confirm that you have read and understand this notice.